A novel model of care; Telemedicine and peer support for HCV care among HIV infected people who inject drugs in remote Myanmar: A retrospective study

doi:10.21203/rs.3.rs-5238109/v1

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A novel model of care; Telemedicine and peer support for HCV care among HIV infected people who inject drugs in remote Myanmar: A retrospective study

https://doi.org/10.21203/rs.3.rs-5238109/v1

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Background: People who inject drugs (PWID) are at a heightened risk of co-infection with HIV and hepatitis C virus (HCV), which adversely affects health outcomes. Uncontrolled HCV can lead to increased transmission rates among PWID, highlighting the urgent need for improved access to treatment as a public health priority. Despite the availability of effective HCV treatments, access remains limited, particularly in remote areas, where stigma further complicates care. Implementing integrated and differentiated HCV care in these regions could help address this gap. This study evaluated a novel care model in remote settings, where general practitioners delivered integrated HCV-HIV care, telemonitored by specialists and supported by community health workers and peer educators. We evaluated treatment outcomes and associated predictors.

Methods: We used routine program data from the HCV treatment register to assess treatment completion rates and sustained virologic response (SVR) among PWID. SVR was defined as an undetectable HCV viral load 12 weeks after treatment completion. Patients who achieved SVR were invited for retesting at one year to calculate the one-year SVR rate. Logistic regression analyses were performed to identify predictors of both SVR and one-year SVR.

Results: Among 314 HIV-HCV co-infected PWID who initiated HCV treatment, 93.0% completed it, 96.2% had 12-week HCV-RNA results, and 77.9% achieved SVR. After one year, 67.7% (126 of 186) maintained SVR. Methadone maintenance therapy (aOR: 2.22; 95% CI: 1.09-4.55) and advanced liver disease—fibrosis (aOR: 2.33; 95% CI: 1.05-5.16) and cirrhosis (aOR: 3.21; 95% CI: 1.13-9.10)—were significantly linked to one-year SVR (p ≤ 0.05).

Conclusion: A novel care model involving general practitioners, specialist telemonitoring, and support from community actors has shown effectiveness for most HIV-HCV co-infected PWIDs. However, further qualitative research is needed to enhance SVR rates and better understand the reasons behind incomplete follow-up.

Hepatitis C virus

HIV coinfection

people who inject drugs

treatment outcomes

general practitioners

community health workers

peer educators

remote setting.

Globally, an estimated 15.6 million adults injected drugs in 2016. Among people who inject drugs (PWID), 17.9% (2.8 million) were infected with HIV, 52.6% (8.2 million) were infected with hepatitis C virus (HCV), and approximately 8.3% (1.3 million) were co-infected with both HIV and HCV (1–3). In Myanmar, a major producer of opium, there are an estimated 116,000 PWIDs, among whom 19.0% are infected with HIV, 47.7% with HCV, and 20.1% of PWIDs are estimated to be infected with both HIV and HCV (4, 5). While the introduction of effective antiretroviral therapy (ART) has improved survival among HIV-infected individuals, HCV-associated mortality remained high in HIV-HCV-coinfected patients (6, 7). The World Health Organization (WHO) has recommended direct-acting antiviral agents (DAAs) for HCV treatment since 2018 (8). A systematic review has highlighted that DAAs can achieve a sustained viral response (SVR), undetectable HCV-RNA at 12 weeks after the completion of HCV treatment in more than 90% of patients with chronic HCV infection. Among those with very advanced stages of cirrhosis, SVR was slightly lower and ranged from 78–87% (9). Although a review of clinical trials showed SVR rates of 95–100% with DAAs among HIV-HCV coinfected general populations, the number of studies in HIV-HCV coinfected PWID was very limited (10). Regarding recurrence after SVR, a meta-analysis has shown that the overall rate of HCV recurrence was 5.9/100 person-years (95% CI 4.1–8.5) among people with recent drug use (injecting or non-injecting) (11). Evidence has shown that HCV-associated liver disease, including fibrosis, cirrhosis, and end-stage liver disease (ESLD), progresses more rapidly in HIV-HCV co-infected individuals (12). Moreover, given the high transmission risks among PWID, ensuring access to treatment for both infections is a critical public health concern.

Few HCV-infected PWIDs have access to HCV treatment globally. The stigmatisation of co-infection with both HIV and HCV, alongside injecting drug use, can exacerbate barriers to HCV treatment access, lead to delayed diagnosis, and ultimately raise mortality rates. Uncontrolled HCV leads to high transmission rates among PWID (13, 14). The urgent need for strategies that reduce stigma and enhance the acceptability of healthcare delivery to improve access to HCV care among PWID is evident (15). A multi-country survey highlighted that embedding HCV services in community-based harm reduction centres improved access to HCV care among PWID (16).

In Myanmar, PWID has been a priority population for HCV elimination since 2017 (5). Nevertheless, treatment access remains limited in Myanmar, particularly in remote areas, with a yearly treatment uptake of less than 1% in HCV-positive PWIDs (5, 13, 17). Murdock and colleagues recommended a novel approach whereby HCV treatment is provided together with other harm reduction services, including prevention and care for HIV, other sexually transmitted infections (STI) and tuberculosis (TB), needle and syringe exchange (NSE), and opiate substitution therapy (OST) in community settings (10). Along these lines, Medical Action Myanmar (MAM), a non-government organisation (NGO) working in Myanmar, initiated a novel HCV treatment program for HIV-HCV coinfected PWID, integrated with other harm reduction services, in a remote community-based HIV clinic. The program, managed by general practitioners (GPs), telemonitored by specialists, and supported by community health workers (CHWs) and peer educators (PEs), may represent a comprehensive and promising strategy in the fight against HCV among HIV-HCV coinfected PWID. This harm reduction model of care for PWID, including a comprehensive package of services, with NSE, naloxone injection, HIV testing and treatment, HCV testing and treatment, has been described in a field note (18). To our knowledge, no previous study assessed HCV treatment outcomes among the specific group of HIV-HCV coinfected PWID, managed by GP’s with the support of telemonitoring, CHWs and PEs. We conducted a retrospective analysis of HCV treatment outcomes among HIV-HCV co-infected people who inject drugs (PWID) enrolled in MAM's integrated HIV-HCV program. We examined the predictors of SVR and one-year SVR, an undetectable HCV viral load one year after achieving SVR, approximately 15 months after completing treatment and discussed how our outcomes compare with those observed in other settings.

2.1. Study setting and procedure

The study took place within MAM's HIV prevention and treatment program in Putao district, Kachin state, Myanmar. Putao is a remote district in northern Myanmar. Most people in Putao rely on agriculture (including opioid cultivation) and work in gold mines, where a growing number of migrant workers work (19). Heroin injection is common in Putao, particularly among miners and in rural communities (20). Access to health services for PWID is exceptionally challenging due to remoteness, poor road infrastructure and lack of public transport. MAM set up the first CHW program in Putao 2014 to provide malaria, TB, and primary health care services to remote communities. The effectiveness of MAM’s CHW-based malaria program has been demonstrated elsewhere (21). The details of the different phases of MAM services in Putao has been published (18) and are briefly presented in Table 1.

HCV diagnosis and Treatment

MAM followed the Myanmar Ministry of Health national guidelines for HCV diagnosis and treatment (17). First, clients were tested with a rapid diagnostic test detecting HCV antibodies to diagnose HCV infection. Those with a positive rapid test were referred for quantitative molecular testing using GeneXpert to confirm HCV infection. Sofosbuvir (SOF) 400 mg plus Daclatasvir (DCV) 60/90 mg or SOF 400 mg plus Velpatasvir (VEL) 100 mg were used for treatment, which on average takes three to six months. Most (96%) patients were treated with SOF 400 mg plus DCV 60/90 mg. Some (4%) were treated with SOF 400 mg plus VEL 100 mg, depending on availability of drugs. MAM assessed the cirrhosis stage with the aspartate transferase (AST) to platelet ratio index (APRI) score and assessed renal function with the plasma creatinine test. SOF/VEL was recommended for 12 weeks regardless of cirrhosis status, while SOF + DCV was extended to 24 weeks if the patient was cirrhotic. Sustained viral response (SVR) was defined as an undetectable HCV viral load 12 weeks after treatment completion. All patients who achieved SVR were invited to return one year later (approximately 15 months after treatment completion) to recheck their HCV-RNA to diagnose HCV recurrence or otherwise confirm one-year SVR.

Table 1

The phases of MAM services with timelines.
Phases	Period	Details
1. The first CHW services for Malaria and TB	2014–2018	MAM set up the first CHW program in Putao to provide malaria, TB, and primary health care services to remote communities.
2. HIV and harm reduction services were added to the clinic and CHW	2018–2020	MAM started an HIV and primary healthcare clinic staffed by GPs, nurses, and peer counsellors, who provided HIV, TB, and STI counselling, testing and treatment, NSE supply, and referral for OST to the public hospital. The existing MAM's Malaria-TB program CHWs were trained to provide NSE, administer naloxone, offer health education related to harm reduction, refer individuals for HIV counselling/testing/OST, and conduct home visits to monitor PWID. MAM also selected, trained, and provided a small incentive to peer volunteers, who provided peer support, health education, and NSE to PWIDs and acted as facilitators between CHW and PWIDs. MAM also set up a mobile medical team with a doctor and PWID PE. The mobile team provided clinic services for PWID and villagers in the communities, including basic health care, family planning, HIV/HCV/STI/TB testing and referrals. The Mobile team also conducted on-the-job training for CHWs and peer volunteers.
3. HCV services were added to the clinic and CHWs	2020 onwards	MAM introduced HCV treatment at the clinic. Before 2020, HCV treatment was not available in Putao. CHWs and PEs provided HCV adherence counselling and monitoring during home visits. A hepatologist from the Hepatitis B Free Foundation, an Australia-based NGO, trained GPs and monitored them weekly via Zoom.

CHW, community health workers, HCV, hepatitis C virus, GPs, general practitioners, MAM, Medical Action Myanmar, NGO, non-government organisation, NSE, needle and syringe exchange, OST, oral substitution therapy, PWID, people who inject drugs, STI, sexually transmitted infection, TB, tuberculosis.

2.2. Study design, population, and period

We retrospectively analysed routinely collected data from PWIDs who initiated HCV treatment between October 2020 and March 2022. The analysis included individuals who were: a) aged 18 years or older, b) HIV positive, c) injecting drugs or had a history of injecting drugs in the past 12 months, d) HCV-treatment naive, e) on antiretroviral therapy (ART), and f) who tested positive for HCV-RNA. The database was closed on September 30, 2023.

2.3. Study variables

The study used routine program data collected from HCV patients' forms. Values recorded during HCV initiation visits were considered as baseline for age, current or interrupted intravenous drug use, taking or not taking methadone maintenance therapy (MMT), APRI score, ART regimen, WHO clinical staging, HIV viral load and HCV viral load. We defined baseline HIV and HCV viral load as those measured on the date closest to initiation of HCV treatment. An APRI score of < 0.5, 0.5 to 1.5, and > 1.5 defined no cirrhosis, fibrosis or risk of cirrhosis and cirrhosis, respectively. The definitions of outcome variables are shown in Table 2.

Table 2

The outcome variables
Outcome	Definitions
Sustained viral response (SVR)	A patient who had an undetectable HCV viral load at 12 weeks after the completion of HCV treatment.
Treatment failure	A patient who had a detectable HCV viral load 12 weeks after the completion of HCV treatment.
Death	A patient who died with any cause of death, either before completing treatment or after treatment completion and before the 12-week HCV result.
Lost to follow-up (LTFU)	A patient who was delayed for three months or more since the planned appointment date, either before completing treatment or after treatment completion and before the 12-week HCV result, for instance, due to imprisonment.
Transferred out (TO)	A patient who was transferred out to a non-MAM facility, either before completing treatment or after treatment completion and before the 12-week HCV result.
One-year SVR	A patient who had an undetectable HCV viral load one year after achieving SVR, approximately 15 months after completing treatment.
HCV recurrence	A patient who had a detectable HCV viral load one year after achieving SVR, approximately 15 months after completing treatment.
Death-after SVR	A patient who died with any cause of death after achieving SVR and before completing a one-year follow-up after SVR.
LTFU-after SVR	A patient who was delayed for three months or more since the planned appointment date after achieving SVR and before completing a one-year follow-up after SVR, for instance, due to imprisonment.
TO-after SVR	A patient who was transferred out to a non-MAM facility after achieving SVR and before completing a one-year follow-up after SVR.
Missed for one year HCV-RNA testing after SVR	A patient who achieved SVR and was under the routine HIV follow-up of the clinic but missed HCV testing one year after achieving SVR.

HCV; hepatitis C virus, MAM; Medical Action Myanmar, SVR; sustained viral response.

2.4. Data collection and management

Any identified HCV-RNA-positive HIV patient at a MAM clinic received a numeric code (HCV code). Medical doctors and counsellors updated paper-based HCV patient files, routinely entered into the HCV database by trained data clerks. CHWs updated individual HCV case forms, which included treatment information. CHWs used a referral form to communicate with the clinic team about patients who experienced side effects, treatment adherence issues, or other problems. No directly identifying information was recorded on any of the HCV-related forms or in the HCV database. The HCV code was used for all medical communication, including linking laboratory results and communication with CHWs. HCV patients received a separate study code before data were extracted into Microsoft Excel to create the study database. The key to linking study codes with HCV codes was password protected and only accessible to the first author. If discrepancies between the HCV database and patient files were detected, original records were verified, and corrections were made. The first author conducted data cleaning and verification.

2.5. Data analysis

Stata Statistical Software (Version 18.0, Stata Corp, Texas 77845 USA) was used for all analyses. Medians and interquartile ranges (IQR) were calculated for numeric variables and proportions for categorical variables. Bivariable and multivariable logistic regression analyses were used to estimate the association between various explanatory variables and SVR and one-year SVR. Patients not evaluated for SVR and one-year SVR were excluded from the respective analyses. Crude and adjusted odds ratios (OR and aOR) and 95% confidence intervals (CI) were reported. We used the Akaike Information Criterion (AIC), a mathematical method. AIC was calculated from the number of independent variables used to build the model and the maximum likelihood estimate of the model (i.e. how well the model reproduces the data). The best-fit model with the lowest AIC score was selected. The P-value of ≤ 0.05 was defined as statistically significant.

This was a retrospective analysis of routinely collected data; no informed consent was sought. The Ministry of Health, Myanmar, approved the program design and treatment protocols in July 2020. Ethical clearance was obtained from the Institutional Review Board of the Institute of Tropical Medicine, Antwerp, Belgium (Reference: IRB/RR/AC/014 1743/24). The Oxford Tropical Research Ethics Committee of the University of Oxford granted a consent waiver and an exemption from ethical review.

4.1. Baseline characteristics

The baseline characteristics of 314 patients who initiated HCV treatment between October 2020 and March 2022 are shown in Table 1. All 314 patients were male, since most of the drug users in the region are men, and the median age was 30 (interquartile range:25–37 years).

Table 1

Baseline characteristics of 314 patients initiated on DAA.
Characteristic	N	%
Sex
Female	0	0.0
Male	314	100.0
Age in years
18–24	68	22.0
25–59	245	78.0
≥ 60	1	0.0
Drug use status
Active	171	54.0
Not active	143	46.0
MMT
Yes	90	29.0
No	224	71.0
Employment
Yes	297	95.0
No	17	5.0
Marital status
Not married	179	57.0
Married	135	43.0
WHO clinical staging of HIV
Stage 1	66	21.0
Stage 2	22	7.0
Stage 3	206	66.0
Stage 4	20	6.0
HIV viral load (copies/ml) (n = 312)
0	255	82.0
1-199	47	15.0
201–499	8	2.0
500–1000	2	1.0
ART regimen
TDF/3TC/EFV	198	63.0
TDF/3TC/DTG	115	37.0
ABC/3TC/DTG	1	0.0
HCV viral load (copies/ml)
0-100,000	64	20.0
100,000-500,000	42	14.0
> 500,000	208	66.0
APRI score
< 0.5	76	24.0
0.5–1.5	187	60.0
> 1.5	51	16.0
HCV treatment regimen
Sofosbuvir + Daclatasvir	301	96.0
Sofosbuvir + Velpatasvir	13	4.0

3TC; lamivudine, ABC; abacavir, APRI score; aspartate transferase and platelet count ratio index score, ART; antiretroviral therapy, DAA; direct-acting antiviral, DTG; dolutegravir, EFV; efavirenz, HCV; hepatitis C virus, MMT; methadone maintenance therapy, PWID; people who inject drugs, TDF; tenofovir disoproxil fumarate. “Active drug use” included PWIDs who were injecting drugs at the time of HCV treatment initiation, and “Not active drug use” included those who were not injecting drugs at the time of HCV treatment initiation but had a history of injecting drugs in the past 12 months.

4.2. HCV treatment outcomes

Among 314 HIV-HCV coinfected PWID who initiated HCV treatment, 93.0% completed treatment. Of those, 96.2% received a 12-week HCV-RNA result, and 77.9% achieved SVR. At one-year follow-up among those with SVR, 67.7% (126/186) had one-year SVR. The detailed outcomes are shown in Fig. 1.

DAA; direct-acting antiviral, HCV; hepatitis C virus, up, RNA; ribonucleic acid, SVR; sustained viral response, missed for testing of one year HCV-RNA after SVR result includes patients who achieved SVR and was under the routine HIV follow-up of the clinic but missed HCV-RNA testing one year after achieving SVR. Stopped for other reasons, including the patients in which the HCV treatment was stopped for either patients’ request or for initiating rifampicin, including anti-tuberculosis treatment.

4.3. Predictors of sustained viral response

In bivariable analysis, apart from age, no variable was significantly associated with SVR. The association between age and SVR was no longer significant when adjusted for other baseline factors (Table 2).

Table 2

Predictors of SVR among 281 HIV/HCV coinfected PWID who completed HCV treatment and had an HCV-RNA result
Variable			Bivariable regression€
	HCV-RNA tested (N)	SVR (N, %)	OR	p-value	95% CI
Age			1.05	0.02	0.01–1.09
Drug use status
Active PWID	155	40 (26)	Ref
Not active PWID	126	22 (17)	1.64	0.10	0.92–2.95
MMT
No	200	49 (25)	Ref
Yes	81	13 (16)	1.70	0.13	0.86–3.33
HCV viral load (copies/ml)
0-100,000	58	13 (22)	Ref
100,001-500,000	34	5 (15)	1.67	0.37	0.54–5.20
> 500,000	189	44 (23)	0.95	0.89	0.47–1.92
APRI score
< 0.5	66	16 (24)	Ref
0.5–1.5	171	41 (24)	1.01	0.97	0.52–1.97
> 1.5	44	5 (11)	2.50	0.10	0.84–7.40
ART regimen
TDF/3TC/EFV	178	39 (22)	Ref
TDF/3TC/DTG	102	23 (23)	0.96	0.90	0.54–1.73
ABC/3TC/DTG	1	0	1.00
HCV treatment regimen
Sofosbuvir + Daclatasvir	269 (89)	59 (22)	Ref
Sofosbuvir + Velpatasvir	12 (92)	3 (25)	0.84	0.80	0.22–3.21

OR; Odd ratio, CI; Confident interval. 3TC; lamivudine, ABC; Abacavir, APRI score; Aspartate transferase and platelet count ratio index (APRI) score, ART; antiretroviral therapy, DAA; direct-acting antiviral, DTG; Dolutegravir, EFV; Efavirenz, HCV; Hepatitis C virus, MMT; methadone maintenance therapy, PWID; people who inject drugs. “Active PWID” included people who were injecting drugs at the time of HCV treatment initiation, and “Not active PWID” included those who were not injecting drugs at the time of HCV treatment initiation but had a history of injecting drugs in the past 12 months. ^€ Different multivariable logistic regression models were constructed using the Akaike Information Criterion, and in the final multivariable model, which included age and drug use status, none of both factors were found to be associated with SVR (not shown in the table).

4.4. Predictors of one-year sustained viral response

Predictors of one-year SVR, among 186 HIV/HCV coinfected PWID who had SVR and who presented for their one-year follow-up testing, are shown in Table 2. People on MMT at the time of HCV treatment and those who had an APRI score of 0.5–1.5 or > 1.5 (versus APRI score < 0.5) were more likely to achieve one-year SVR in multivariable analysis. Discontinuation of injectable drug use at HCV treatment start was associated with one-year SVR in bivariable analysis but not in multivariable analysis.

Table 3

Predictors of one-year SVR among 186 HIV/HCV coinfected PWID with SVR results.
Variable			Bivariable			Multivariable^$
	one-year HCV-RNA tested (N)	one-year SVR (No, %)	OR	p-value	95% CI	aOR	p-value	95% CI
Age			0.98	0.41	0.95–1.02	0.98	0.23	0.93–1.02
Drug use status
Active PWID	99	60 (61)	Ref
Not active PWID	87	66 (76)	2.04	0.03	1.08–3.86
MMT
No	123	77 (63)	Ref			Ref
Yes	63	49 (78)	2.09	0.04	1.04–4.20	2.22	0.03	1.09–4.55
HCV viral load (copies/ml)
0-100,000	36	25 (69)	Ref
100,001-500,000	26	19 (73)	1.19	0.76	0.39–3.64
> 500,000	124	82 (66)	0.86	0.71	0.38–1.91
APRI score
< 0.5	37	20 (54)	Ref			Ref
0.5–1.5	113	79 (70)	1.98	0.08	0.92–4.23	2.33	0.04	1.05–5.16
> 1.5	36	27 (75)	2.55	0.07	0.94–6.89	3.21	0.03	1.13–9.10
ART regimen
TDF/3TC/EFV	117	77 (66)	Ref
TDF/3TC/DTG	69	49 (71)	1.26	0.46	0.67–2.43
ABC/3TC/DTG	0	0
HCV treatment regimen
Sofosbuvir + Daclatasvir	177	119 (67)	Ref
Sofosbuvir + Velpatasvir	9	7 (78)	1.71	0.51	0.34–8.47

OR; Odd ratio, aOR; Adjusted odd ratio, CI; Confident interval. 3TC; lamivudine, ABC; Abacavir, APRI score; Aspartate transferase and platelet count ratio index (APRI) score, ART; antiretroviral therapy, DAA; direct-acting antiviral, DTG; Dolutegravir, EFV; Efavirenz, HCV; Hepatitis C virus, MMT; methadone maintenance therapy, PWID; people who inject the drugs, TDF; tenofovir disoproxil fumarate. “Active PWID” included people who were injecting drugs at the time of HCV treatment initiation, and “Not active PWID” included those who were not injecting drugs at the time of HCV treatment initiation but had a history of injecting drugs in the past 12 months. ^$Different multivariable logistic regression models were constructed, and the best-fitting model was selected using the Akaike Information Criterion (AIC).

This is the first study showing results of a novel model of care for HCV-HIV co-infected patients in remote Myanmar, managed at a community-based clinic by GPs, telemonitored by specialists, and supported by CHW and PE. Among HIV-HCV coinfected PWID who initiated HCV treatment, 93.0% completed DAA therapy. Of these, 96.2% received a 12-week HCV-RNA result, with 77.9% achieving SVR. At one-year follow-up, 67.7% of those with SVR remained HCV negative. Taking MMT at the time of HCV treatment initiation and increasing levels of liver disease (higher APRI score) were associated with achieving one-year SVR.

Among 314 patients in our cohort who initiated DAA treatment, 93.0% completed the treatment, and of those 96.2% returned for an HCV-RNA test after 12 weeks. The EuroSIDA studies, covering 36 European countries, among HIV-HCV coinfected patients -of whom 56.1% were PWIDs-, reported a similar DAA completion rate with 94.4% (1598/1693), while only 74.8% (1195/1598) came back for an HCV RNA test after treatment completion (22). Our data suggests that decentralizing HCV care at the GP level with tele-support in remote areas is feasible and compares well with outcomes of other HCV care models in developed settings. HCV-positive PWID from Puerto Rico completed only 70% of DAA treatment, citing reasons such as lack of transportation, fear of side effects, and long waiting times with HCV treatment providers (22). A study from the Tel Aviv Sourasky Medical Center highlighted that the need for a specialist visit was the main gap in the HCV care cascade for coinfected PWID and recommended decentralising care (23). Designing and implementing new integrated approaches to meet the targeted PWID communities is essential to bridge the service gaps for PWID (24).

Our study demonstrated an SVR rate of 77.9% (219/281). This outcome aligns well with findings from PWID in the HCV-infected and HIV-HCV-coinfected cohorts in Myanmar, where PWID achieved an SVR of 76.7% (25). Similarly, a cohort of HIV-HCV coinfected patients, with 73.4% PWID managed at hepatology clinics in Israel, reported an SVR of 79.2% (80/101) (23). However, clinical trials using DAA have reported higher SVR rates, ranging from 95–100% among the general HIV-HCV coinfected population (26). Many factors are at play. The choice of DAA regimen, patient and population characteristics, injectable drug use, OST use, HCV genotype, and liver fibrosis stage explain differences in SVR rates (23, 25, 27–29).

Our study also highlighted that 67.7% (126/186) remained HCV-RNA negative one year after achieving SVR. Notably, being on MMT at the time of HCV treatment initiation significantly lowered the risk of recurrence in our cohort. However, a systematic review highlighted the importance of recent drug use regardless of OST status on HCV recurrence rates among PWID. Across 36 studies, the review found that HCV recurrence was higher among those with recent drug use, whether they were receiving OST (aRR 3.50; 95% CI 1.62–7.53) or not (aRR 3.96; 95% CI 1.82–8.59), compared to those on OST without recent drug use. (11). Our results underscore the importance of implementing the DAA program in conjunction with other harm reduction services, including drug use counselling, OST and NSP (11, 30), to maximise the impact of HCV treatment and reduce the risk of recurrence.

In our study, HCV-HIV coinfected PWIDs with APRI scores indicating higher levels of liver disease (fibrosis, cirrhosis) at the time of HCV treatment initiation had a higher likelihood of achieving one-year SVR. However, a contrasting finding was reported in a study from Taiwan, where coinfected PWIDs with a history of cirrhosis at the time of treatment initiation were associated with an increased risk of recurrence (31). Since non-invasive liver disease assessments among PWIDs have been shown to promote positive health outcomes, we hypothesise that PWIDs in our cohort became more aware of the condition of their liver during the liver staging assessment at HCV treatment initiation. This increased awareness may have contributed to changes in their lifestyle, substance use behaviour, or treatment adherence, ultimately influencing their health outcomes (32).

There are several limitations to consider when interpreting our results. Since it is a retrospective study, we cannot estimate the causal effect of MMT on one-year SVR. Due to budget constraints, we could do the HCV-RNA follow-up testing only once, about 12 months after SVR, and we were unable to calculate the HCV reinfection rate per 100 person-years among those with SVR. Additionally, because of budget constraints, we could not perform next-generation sequencing (NGS) phylogenetic analysis and could not distinguish between relapse or reinfection. Though poor pill compliance among HCV-positive-PWID was a significant factor in treatment failure in another study (33), we were not able to assess its effect in our analysis due to missing data. However, our study has notable strengths. It is the first to analyse real-life experiences in remote settings managed by GPs, telemonitored by specialists, and supported with integrated CHW and PE in Myanmar. The first author initiated the program and was deeply involved in its operations, including patient management, the prospective collection of program data, and source file review to address any missing data or uncertainties. This close involvement instils confidence in the accuracy of the database, reflecting the reality of the program.

Our study confirms that a novel model of decentralising HCV treatment at the community level is feasible and effective in addressing gaps in the HCV care continuum for coinfected PWIDs. This model demonstrates the potential to bridge treatment gaps and advocates for its adoption in similar settings. However, a more in-depth understanding of the reasons for not completing follow-up is necessary to further improve SVR and one-year SVR.

Author Contribution

NNT and FS conceived the idea, designed the program, and conducted the program.FS supervised the program and data acquisition. NNT, MMMH and NLT performed data acquisition and analysis. TD and TG supported the statistical analysis. NNT drafted the first version of the manuscript and prepared the figures and tables.All authors reviewed and approved the manuscript.

Acknowledgement

We would like to thank the study persons, the medical and data teams from Medical Action Myanmar and the Myanmar Oxford Clinical Research Unit, Yangon, Myanmar.

Data Availability

Data is provided within the manuscript with Figure and Tables.

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A novel model of care; Telemedicine and peer support for HCV care among HIV infected people who inject drugs in remote Myanmar: A retrospective study

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Abstract

Figures

1. Background

2. Methods

2.1. Study setting and procedure

2.2. Study design, population, and period

2.3. Study variables

2.4. Data collection and management

2.5. Data analysis

3. Ethics statement

4. Results

4.1. Baseline characteristics

4.2. HCV treatment outcomes

4.3. Predictors of sustained viral response

4.4. Predictors of one-year sustained viral response

5. Discussion

6. Conclusion

Declarations

Author Contribution

Acknowledgement

Data Availability

References

Additional Declarations

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